Development and Validation of (Bio)Sensors for the Identification of Pathogens

Recruiting

• Conditions: Infection, Parasite; Pseudomonas Aeruginosa Infection; Infections; Leishmania Infantum Disease; Infection, Bacterial; Infection Viral; SARS CoV 2 Infection
• Interventions: Other: Nanobiotechnology platforms

• Registration Number: NCT06548841
• Lead Sponsor: University of Bologna

Brief Summary

The recent COVID-19 pandemic has revealed the need to develop tests that are accurate, rapid, and inexpensive for the diagnosis of infectious diseases. This problem is relevant not only for viruses, but also for bacteria and parasites: the identification of pathogens at low concentrations by simple and accurate methods is still largely unsatisfied because these microorganisms are structurally complex and are incorporated in composite and diverse biological samples, which can create relevant interferences in pathogens' detection. Direct diagnostic approaches, such as microscopic examination, culture and molecular testing are carried out in equipped laboratories and require long waiting times to obtain the results. Recently developed point-of-care (POC) tests are a group of technologies that miniaturize tests into portable devices such that they can be performed both in well-equipped laboratories and outside the conventional laboratory setting. The present study aims to explore the feasibility and adaptability of newly developed platforms to detect: 1. a virus (SARS-CoV2), 2. a bacterium (Pseudomonas aeruginosa) and 3. a protozoan parasite (Leishmania infantum) in clinical specimens, such as blood and respiratory samples. These newly developed platforms are expected to overcome the current limitations of molecular testing (high cost, time required and need for well-equipped laboratories) and rapid testing (high number of false-negative results). In addition, the newly developed platforms may have important clinical application in low-income countries, which will benefit from a simple and inexpensive approach to detect the many infectious diseases that affect millions of people each year.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-30
• Study First Submitted: 2024-07-30
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12
• Primary Completion: 2025-09-02
• Study Completion: 2025-11-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Obtaining informed consent
• Age ≥ 18 years
• Patients who meet one of the following conditions: SARS-CoV2 positive patients (group 1), SARS-CoV2 negative patients (group 2), P. aeruginosa positive patients (group 3), P. aeruginosa negative patients (group 4), L. infantum positive patients (group 5), L. infantum negative patients (group 6).

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
P. aeruginosa positive patients	Nanobiotechnology platforms	Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, prospective cohort.
SARS-CoV2 negative patients	Nanobiotechnology platforms	Patients recruited at Personal Genomics (centre based in Verona), retrospective cohort.
L. infantum positive patients	Nanobiotechnology platforms	Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, retrospective and prospective cohort.
P. aeruginosa negative patients	Nanobiotechnology platforms	Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, prospective cohort.
L. infantum negative patients	Nanobiotechnology platforms	Patients recruited at IRCCS Azienda Ospedaliero-Universitaria di Bologna, retrospective and prospective cohort.
SARS-CoV2 positive patients	Nanobiotechnology platforms	Patients recruited at Personal Genomics (center based in Verona, partner of the European project ECLIPSE), retrospective cohort.

Primary Outcome Measures

Name	Time	Method
The evaluation of the sensitivity and specificity of new nanobiotechnological platforms compared to gold standard diagnostic tests	16 months	The sensitivity and the specificity will be estimated by creating the confusion matrix corresponding to the classification between signals significant (beyond Limit Of Detection, LOD) and samples giving non-significant signals (below LOD).; Where the analytical problem is described by other variables than the electrochemiluminescent analytical signal, multivariate classification methods shall be applied. The correlation and interaction between variables will also be estimated.

Trial Locations

Locations (1)

Department of Medical and Surgical Sciences, University of Bologna; 🇮🇹 Bologna, Italy